ALINITY C 葡萄糖試劑套件，ALINITY C 系統
K 號：K170316 · 2017-10-19
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器材摘要
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 2017-10-19 under 510(k) number K170316. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is a medical device that received FDA 510(k) clearance on 2017-10-19. The listed applicant is Abbott Laboratories. The 510(k) number is K170316.
When did ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM receive FDA 510(k) clearance?
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM received FDA 510(k) clearance on 2017-10-19, under 510(k) number K170316.
Who is the listed applicant for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?
FDA 510(k) 記錄中將阿培爾實驗室列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM?
The FDA product code for ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM is CFR.
相關臨床試驗
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其他以 Abbott Laboratories 為申請人之記錄
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
相關器械（代碼：CFR）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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